Clinical and radiographic outcomes of NeoMTA and NeoPUTTY pulpotomies in primary molars: A Randomized Controlled Trial
Victor Thibeault 1,2 Xiaolu Lisa Mai 1, 2, Edwin Chan 1,2, Beatriz Ferraz Dos Santos
1Division of Dentistry, Montreal Children’s Hospital, 2Faculty of Dental Medicine and Oral Health Sciences, McGill University
Background: Pulpotomy is a commonly performed procedure on vital primary molars. The use of mineral trioxide aggregate (MTA) or diluted formocresol (FC) is recommended for optimal outcomes. Recently, great interest was focused on NeoMTA, a novel low-cost alternative to MTA. In a recent study conducted by our research group, we found that NeoMTA pulpotomies have similar survival and success rate and a significantly higher radiographic success than FC pulpotomies. However, one of the challenges of NeoMTA is the hand mixing of the material. To overcome this difficulty, NeoPUTTY, a premixed calcium silicate-based bioceramic material was developed and has the advantage of not requiring any manipulation. However, due to its recent commercialization, there is limited evidence to support the use of NeoPUTTY as a medicament for primary teeth pulpotomies. Thus, this study aims to evaluate the survival, clinical and radiographic outcomes of NeoPUTTY and NeoMTA pulpotomies in primary molars over a 24-month period.
Methodology: This single-site, double-blinded randomized clinical trial with parallel groups will be conducted at the Montreal Children’s Hospital. Healthy children aged between 3 and 8 years undergoing dental care under general anesthesia who have one or more primary molars requiring a pulpotomy will be included. To account for a desired accuracy of 20%, a significance level of 5%, and a safety margin of 20%, a minimum sample size of 47 teeth in each group will be required. Participants’ primary molars will be randomly assigned (1:1 ratio) into two groups: i) pulpotomy with NeoMTA; and ii) pulpotomy with NeoPUTTY. All pulpotomies will be performed by trained staff dentists following a strict protocol. Follow-up visits at 1, 6, 12 and 24 months will be conducted to assess clinical
and radiographic outcomes. This project is under ethics review at the Review Ethics Board of the McGill University Health Centre. Clinical significance and knowledge translation: Our study will be the first to compare the long-term outcomes of NeoMTA and NeoPutty pulpotomies in primary dentition. As such, we anticipate three modes of knowledge translation: 1) a manuscript; 2) dissemination of results at scientific conferences and to the dental community; and 3) a future cost-effectiveness study that explore financial sustainability for the use of NeoPUTTY over NeoMTA in a setting of governmental covered pediatric dental care.